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U.S. Department of Health and Human Services

Emergency Preparedness and Response

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MCM Legal, Regulatory and Policy Framework

Stethoscope with booksThe FDA Medical Countermeasures Initiative (MCMi) legal, regulatory, and policy framework ensures that U.S. laws, regulations and policies help support preparedness and response for potential chemical, biological, radiological, nuclear (CBRN) and emerging infectious disease threats. MCMi also helps facilitate advances in regulatory science available for practical use in the regulatory review process.

To do so, FDA assesses strengths and weaknesses of current medical countermeasure (MCM)-related development, distribution, administration, and use. We work with appropriate partners to develop and propose new approaches, where changes are needed to better protect public health.



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